Drugplain

Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1

Emtricitabine and Tenofovir Disoproxil Fumarate · TABLET, FILM COATED · Amneal Pharmaceuticals NY LLC

No Recall History
Plain English

Emtricitabine and Tenofovir Disoproxil Fumarate is a tablet, film coated containing emtricitabine and tenofovir disoproxil fumarate at 200 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals NY LLC.

Key Facts

Brand Name
Emtricitabine and Tenofovir Disoproxil Fumarate
Generic Name
Emtricitabine and Tenofovir Disoproxil Fumarate
NDC Code (Product)
69238-2095
Manufacturer
Amneal Pharmaceuticals NY LLC
Strength
200 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA209721
Drug Class
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Marketing Start
08/26/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

foetal exposure during pregnancy48 reports
exposure during pregnancy36 reports
maternal exposure during pregnancy21 reports
abortion spontaneous20 reports
drug exposure during pregnancy14 reports
anaemia13 reports
drug interaction13 reports
pyrexia12 reports
vomiting12 reports
diarrhoea11 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ) Emtricitabine and tenofovir disoproxil fumarate tablet is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): • Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablet for HIV-1 PrEP. 1.1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies ( 14 )] . 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-ri…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Testing: Prior to or when initiating emtricitabine and tenofovir disoproxil fumarate tablets test for hepatitis B virus infection. Prior to initiation and during use of emtricitabine and tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus. ( 2.1 ) • HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP and at least once every 3 months while taking emtricitabine and tenofovir disoproxil fumarate tablets, and upon diagnosis of any other sexually transmitted infections (STIs). ( 2.2 ) Treatment of HIV-1 Infection • Recommended dosage in adults and pediatric patients weighing at least 35 kg: One emtricitabine and tenofovir disoproxil fumarate tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food. ( 2.3 ) • Recommended dosage in pediatric patients weighing at least 17 kg: One emtricitabine and tenofovir …

Contraindications

4 CONTRAINDICATIONS Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions ( 5.2 )] . Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. ( 7.2 ) • Coadministration decreases atazanavir concentrations. When coadministered with emtricitabine and tenofovir disoproxil fumarate, use atazanavir given with ritonavir. ( 7.2 ) • Coadministration of emtricitabine and tenofovir disoproxil fumarate with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. ( 7.2 ) • Consult Full Prescribing Information prior to and during treatment for important drug interactions. ( 7.2 ) 7.1 Drugs Affecting Renal Function FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion [see Clinical Pharmacology ( 12.3 )]. No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration of emtricitabine and tenofovir disoproxil fumarate with drugs that are eliminated by active tubular secretion may increase concentrations of FTC, tenofovir, and/or the coadministered drug. Some examples in…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions ( 5.1 )] . • New Onset or Worsening Renal Impairment [see Warnings and Precautions ( 5.3 )] . • Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.4 )] . • Bone Loss and Mineralization Defects [see Warnings and Precautions ( 5.5 )]. • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions ( 5.6 )] . • In HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. ( 6.1 ) • In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of emtricitabine and tenofovir disoproxil fumarate participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Be…

Frequently Asked Questions

What is Emtricitabine and Tenofovir Disoproxil Fumarate used for?

Emtricitabine and Tenofovir Disoproxil Fumarate contains Emtricitabine and Tenofovir Disoproxil Fumarate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Emtricitabine and Tenofovir Disoproxil Fumarate a controlled substance?

Emtricitabine and Tenofovir Disoproxil Fumarate is not classified as a controlled substance by the DEA.

What is the generic name for Emtricitabine and Tenofovir Disoproxil Fumarate?

The generic name for Emtricitabine and Tenofovir Disoproxil Fumarate is Emtricitabine and Tenofovir Disoproxil Fumarate. There are 7 other brand versions of Emtricitabine and Tenofovir Disoproxil Fumarate.

What is the NDC code for Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1?

The NDC (National Drug Code) for Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1 is 69238-2095, listed by Amneal Pharmaceuticals NY LLC.

Product NDC

69238-2095

Package NDC

69238-2095-3

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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